Contract position: A Validation Specialist is needed for a global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient's needs in the Swiftwater, PA area. No per diem available.Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Working closely with subject matter experts (SME) to generate validation documents compliant with the site policies and procedures. Perform validation sampling and data analysis of the results.
- Ensure proper execution/documentation of test results, and compilation of validation packages. Retrieve and compile data from electronic sources / databases and paper records.
- Analyze data. Responsible for authoring, reviewing, executing and approving validation documents. Assist in writing Standard Work Instructions and Batch Production Records. Provide Fermentation Expertise.
- Experience in writing protocols/reports in Pharmaceutical Bio Pharma Validation industries to include Process Validation. Experience with fermentation processes.
- Technical writing abilities and good time management. Strong root cause analysis skills with cGMP experience.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.